YM BioSciences Inc, a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, announced that its wholly-owned subsidiary, YM BioSciences USA Inc. (YM-USA) has received a license from the US Department of the Treasury's Office of Foreign Assets Control (OFAC) to further develop its lead product, Nimotuzumab, for patients with solid tumour cancers in the United States.

"This license from OFAC to develop Nimotuzumab in any cancer indication is a major step forward in our US development programme and will allow us to immediately discuss our IND submissions with the FDA to include US patients in our randomized, double-blinded lung cancer and brain metastases trials," said David Allan, chairman and CEO of YM BioSciences.

"Our development plans may also include extending some of the phase-III trials being conducted worldwide into the US. There are quantifiable physical, emotional and financial costs that result from the numerous and severe toxicities of the currently available EGFR-targeting drugs which are not evident with the administration of our drug. Nimotuzumab has been demonstrating efficacy in trials throughout the world and we are very pleased that US patients will now have the opportunity to receive the drug and that a broader group of US oncologists will gain experience with it. Our goal is to bring this therapeutic option, already approved for marketing in 18 countries, to patients in the US as rapidly as possible," informed David.

Allan added, "We have also applied to OFAC for a license to make Nimotuzumab available to US patients upon marketing approval by the FDA. This is consistent with a 2009 Staff Report to the US Senate Committee on Foreign Relations (SCFR) entitled 'Changing Cuba Policy - In the United States' National Interest,' which recommended pharmaceutical imports from Cuba's rapidly developing biotech industry. We are most appreciative of the extensive support we have received for our application from SCFR chairman Senator John Kerry (D-MA), Western Hemisphere Subcommittee chairman Senator Chris Dodd (D-CT) and SCFR Ranking Member Senator Richard Lugar (R-IN) and for their acute understanding of the needs of cancer patients. Such licenses have been previously granted to two companies seeking to commercialize Cuban-origin therapeutics in the US and we have ongoing discussions with OFAC in this regard."

YM USA previously received a license from OFAC to import Nimotuzumab into the US to conduct a study of Nimotuzumab in children suffering from recurrent diffuse intrinsic pontine glioma. This trial is ongoing at 10 of the principal oncology hospitals in the US and data is expected in 2010. Nimotuzumab is also available on a compassionate use basis in the US for children with this condition and is designated an Orphan Drug for adult and paediatric glioma by the FDA as well as the EMEA for Europe.

Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR), licensed to YM's majority-owned subsidiary, CIMYM BioSciences Inc, by CIMAB S.A., and developed at the Center of Molecular Immunology in Cuba. The drug has demonstrated efficacy in clinical trials without the serious side effects observed with the marketed EGFR-targeting drugs. Nimotuzumab has been administered to approximately 5,000 patients worldwide and is currently in 32 trials internationally of which 11 are being conducted by YM and its four licensees. Three of the latter are phase-III trials, including one being conducted by the internationally recognized National Cancer Center of Singapore, which selected Nimotuzumab over the alternative antibodies because of its benign side effect profile.

YM BioSciences is a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development.